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Diabetic Foot UlcerNCT06453187

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

A study testing Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers and AmnioExcel Plus for Venous Leg Ulcers in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Integra LifeSciences Corporation at 13 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Foot Ulcer, Venous Leg Ulcer
What is being tested?
Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers and AmnioExcel Plus for Venous Leg Ulcers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
13 sitesUnited States
Study dates
18 Nov 2024to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must be at least 21 years of age or older.
  • Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
  • At Screening Visit 1 and at Randomization, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
  • The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
  • The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
  • The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the malleolus.
Show all 28Show fewer
  • The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
  • ABI between 0.7 and 1.3;
  • TBI greater or equal to 0.6;
  • TCOM greater or equal to 40 mmHg;
  • PVR: biphasic.
  • If the potential subject has two or more ulcers, they must be separated by at least 2 cm post debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
  • Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
  • The potential subject must consent to using the prescribed offloading method for the duration of the study.
  • The potential subject must agree to attend the weekly study visits required by the protocol.
  • The potential subject must be willing and able to participate in the informed consent process.
  • Subjects must be at least 21 years of age or older.
  • At Screening Visit 1 and at Randomization subjects must have a target ulcer with a minimum surface area of 1 cm2 and a maximum surface area of 20 cm2 measured post-debridement.
  • The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
  • Nonapplicable in this protocol version.
  • The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:
  • ABI between 0.7 and ≤ 1.3;
  • TBI ≥ 0.6;
  • TCOM ≥ 40 mmHg;
  • PVR: biphasic.
  • If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
  • The potential subject must agree to attend the weekly study visits required by the protocol.
  • The potential subject must be willing and able to participate in the informed consent process.

Who cannot join

  • The potential subject is known to have a life expectancy of < 6 months.
  • The potential subject's target ulcer is not secondary to diabetes.
  • The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
  • The target ulcer exposes tendon or bone.
  • There is evidence of osteomyelitis complicating the target ulcer.
  • The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the Pl believes will interfere with wound healing such as biologics (monoclonal antibodies, therapeutic proteins and enzymes, gene therapies, cell therapies, cytokines and growth factors and certain vaccines) - Refer to Appendix N for a list of medications .
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  • The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
  • The potential subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
  • The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
  • Nonapplicable in this protocol version.
  • The surface area measurement of the Target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
  • The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
  • Women who are pregnant or considering becoming pregnant within the next 6 months.
  • The potential subject has end stage renal disease requiring dialysis.
  • Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
  • A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
  • The target ulcer was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
  • The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutrition Assessment.
  • A subject has a wound with active or latent infection as determined by the Investigator.
  • A subject with a disorder that would create unacceptable risk of post-operative complications.
  • The potential subject has a sensitivity to ethanol or porcine materials.
  • The potential subject is known to have a life expectancy of < 6 months.
  • The target ulcer is infected as determined by the Investigator, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.
  • The target ulcer exposes tendon or bone.
  • There is evidence of osteomyelitis complicating the target ulcer.
  • The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing such as biologics (monoclonal antibodies, therapeutic proteins and enzymes, gene therapies, cell therapies, cytokines and growth factors and certain vaccines)- Refer to Appendix N for a list of medications.
  • The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
  • The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the Randomization visit.
  • Nonapplicable in this protocol version.
  • The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.
  • Women who are pregnant or considering becoming pregnant within the next 6 months.
  • The potential subject has end stage renal disease requiring dialysis.
  • Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
  • A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
  • The potential subject was treated with hyperbaric oxygen therapy (HBOT) or CAMP in the 30 days prior to the initial screening visit.
  • The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutrition Assessment
  • A subject has a wound with active or latent infection as determined by the Investigator.
  • A subject with a disorder that would create unacceptable risk of post-operative complications.
  • The potential subject has a sensitivity or allergy to ethanol or porcine materials.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

13 sites in 1 country

United States13 sites

  • Denali Health

    Atlanta, Georgia, 30083

  • MedStar Franklin Square Medical Center

    Baltimore, Maryland, 21044

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • Family Foot & Ankle Specialists, LLC

    Bridgeport, Connecticut, 06606

  • SitePath Research

    Evergreen Park, Illinois, 60805

  • Midwest Foot and Ankle Clinics

    Hoffman Estates, Illinois, 60169

  • Louisiana Foot & Ankle Specialists

    Lake Charles, Louisiana, 70605

  • Comprehensive Wound Healing Center, Northwell Health

    Lake Success, New York, 11042

  • Angel City Research

    Los Angeles, California, 90010

  • Denali Health Plant City, LLC

    Plant City, Florida, 33564

  • Center for Clinical Research

    San Francisco, California, 94115

  • Barry University Clinical Research

    Tamarac, Florida, 33321

  • ILD Research Center

    Vista, California, 92081

Other trials in United States

About this study

Official title: Multicenter, Prospective, Randomized, Controlled Platform Trial Assessing Clinical Utility of Cellular, Acellular and Matrix-like Products (CAMPs) and Standard of Care vs SOC Alone in Hard-to-Heal Diabetic Foot and Venous Leg Ulcers.

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Read the detailed description

Hard to heal Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of hard to heal chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SC) treatment and frequently become infected.

Advanced wound products like CAMPs have become an important strategy in the treatment of hard-to-heal chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.

The study will evaluate the clinical utility of Multiple CAMPs in the closure of hard to heal diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.

Being tested
Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers, AmnioExcel Plus for Venous Leg Ulcers, AmnioExcel Plus for Diabetic Foot Ulcers, Standard of Care
Medical subject headings
Diabetic Foot, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urinary Bladder Matrix (UBM) sheet device for Venous Leg UlcersDevice

    Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot UlcersDevice

    Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • AmnioExcel Plus for Venous Leg UlcersDevice

    Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • AmnioExcel Plus for Diabetic Foot UlcersDevice

    Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

  • Standard of CareProcedure or surgery

    Participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Study groups in NCT06453187
Study groupRoleWhat they receive
Venous Leg Ulcers with a Urinary Bladder Matrix (UBM) sheet deviceExperimentalParticipants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Receives: Device: Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers; Procedure: Standard of Care
Diabetic Foot Ulcers with Urinary Bladder Matrix (UBM) sheet deviceExperimentalParticipants will receive treatment with Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Receives: Device: Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers; Procedure: Standard of Care
Venous Leg Ulcers with AmnioExcel PlusExperimentalParticipants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Receives: Device: AmnioExcel Plus for Venous Leg Ulcers; Procedure: Standard of Care
Diabetic Foot Ulcers with AmnioExcel PlusExperimentalParticipants will receive treatment with AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Receives: Device: AmnioExcel Plus for Diabetic Foot Ulcers; Procedure: Standard of Care
Standard of CareActive comparatorBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Receives: Procedure: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of complete wound closure for target ulcer

    The percentage of target ulcers, DFU and VLU, achieving complete wound closure Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate

    Measured: 1-12 weeks

Secondary outcomes (6)

  1. Time to complete wound closure for target ulcer

    Time to closure will be determined for each treatment group and compared to SOC

    Measured: 1-12 weeks

  2. Percentage of wound area reduction for target ulcer

    Percent Area Reduction (PAR) will be calculated from measurements at Week 1 compared to measurements at week 12

    Measured: 1-12 weeks

  3. Adverse Events

    Incidence of adverse events will be evaluated weekly from the first study visit to the Closure Confirmation Visit (CCV).

    Measured: 1-14 weeks

  4. Changes to pain associated with the target ulcer

    Change in target ulcer pain assessed weekly from the first study visit to the Closure Confirmation Visit (CCV), using a 0 to 10 Pain scale with 0 = "No Pain" and 10 = "Most Intense Pain Imaginable".

    Measured: 1-14 weeks

  5. Determine improvement in Quality of Life

    Quality of Life assessed at the study randomization visit and the Closure Confirmation Visit (CCV), using a Minimal Important Difference (MID) of 0.50 based on the averaged overall score from 0 to 4 of all items the Wound Quality of Life (wQOL) checklist, with higher score indicating worse wQOL

    Measured: 1-14 weeks

  6. Improvement of the Forgotten Wound Score (FWS)

    Forgotten Wound Score (FWS) assessed at the study randomization visit and the Closure Confirmation Visit (CCV) based a 0 to 100 scale with higher indicating a high degree of "forgetting" the wound

    Measured: 1-14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start18 Nov 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06453187
Sponsor's protocol ID
T-WOUNDS-001
Status last verified
Jul 2026
First submitted
7 Jun 2024
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Urinary Bladder Matrix (UBM) sheet device for Venous Leg Ulcers, Urinary Bladder Matrix (UBM) sheet device for Diabetic Foot Ulcers and AmnioExcel Plus for Venous Leg Ulcers in people with Diabetic Foot Ulcer and Venous Leg Ulcer, run by Integra LifeSciences Corporation at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of complete wound closure for target ulcer (time frame: 1-12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06453187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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